1. Name Of The Medicinal Product
Disprol Soluble Paracetamol Tablets.
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Soluble tablet.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of mild to moderate pain, including headache, migraine, neuralgia, pain in teething, toothache, sore throat, aches and pains. Symptomatic relief of rheumatic aches and pains. Symptomatic relief of influenza, feverishness and feverish colds.
4.2 Posology And Method Of Administration
Oral administration. Dissolve tablets in half a tumbler of water.
Children 3 months to under 1 year: half to one tablet every four hours (maximum of four tablets in 24 hours).
Children 1 year to under 6 years: one to two tablets every 4 hours (maximum of eight tablets in 24 hours).
Children 6 years to 12 years: two to four tablets every 4 hours (maximum of 16 tablets in 24 hours).
Not to be given to children under 3 months except on a doctor's advice. Dosage should not be continued for more than 3 days without consulting a doctor.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other constituents.
4.4 Special Warnings And Precautions For Use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Patients should be advised not to take other paracetamol-containing products concurrently.
Label warning: Do not exceed the stated dose. If symptoms persist, consult your doctor. Keep out of the reach of children. Contains paracetamol (panel).
Do not give with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if the child seems well.
Leaflet: Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates and tricyclic anti- depressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
4.6 Pregnancy And Lactation
Epidemiological studies in human pregnancy have shown no ill-effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.
4.7 Effects On Ability To Drive And Use Machines
None stated.
4.8 Undesirable Effects
Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
4.9 Overdose
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.
5.2 Pharmacokinetic Properties
Paracetamol is absorbed rapidly and completely mainly from the small intestine, producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a half-life of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that covered in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium bicarbonate,
Sodium carbonate,
Sodium saccharin,
Citric acid,
Maltodextrin 01915,
Fantasy lime flavour 17.42.4763
Magnesium stearate.
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Store in a dry place below 30°C.
6.5 Nature And Contents Of Container
Tablets are contained in a strip pack formed round individual tablets consisting of 30 microns soft temper aluminium/5.5 gsm heat seal vinyl lacquer strips containing 6, 8, 12, 16, 18, 24 or 48 tablets. The strips of blisters are contained in an outer cardboard carton.
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, UK.
8. Marketing Authorisation Number(S)
PL 0063/0022.
9. Date Of First Authorisation/Renewal Of The Authorisation
24th April, 1995 / 23/04/2001
10. Date Of Revision Of The Text
July 2005.
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